US FDA issues seven observations on Sun Pharma's Mohali site

Referencing to a precision balance instrument, the FDA said there was no password protection and noted, "Laboratory analysts have the ability to change instrument settings including date and time on the instrument."ET Bureau | November 24, 2016, 17:38 IST

MUMBAI – The US FDA recorded seven observations as part of its recent inspection of Sun Pharma’s manufacturing site at Mohali. The site, which was earlier used to ship generic versions of popular cholesterol drug atorvastatin to the US, was brought under an import alert by the drug regulatory agency in Sept 2013.

Sun Pharma did not comment on the issue. The observations, addressed to Jila Breeze, Senior VP and head of global quality and compliance at Sun Pharma raised issues with the review process for the failure of a batch or any of its components in meeting specifications. In another observation, the FDA noted that laboratory records did not include complete data derived from all tests, examination and assay necessary to assure compliance with established specifications and standards.

As its third observation, the US FDA officials represented by a team of three investigators, Steven Kehoe, Felix Maldonaldo and Daniel Roberts, said in the report that appropriate controls were not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.

Referencing to a precision balance instrument, the FDA said there was no password protection and noted, "Laboratory analysts have the ability to change instrument settings including date and time on the instrument."

"The quality control unit lacks authority to review production records to assure that no errors have occurred," the FDA added as part of its fifth observation related to good documentation practices in the quality systems. Another observation related to production system said no written procedures for production and process controls were designed to assure that the drug products have the identity, strength, quality and purity they purport or are represented to possess.

Analysts told ET the FDA observations are not very serious in the initial reading but it depends on how these deviations are interpreted by the investigators. “Mohali was expected to be less complicated. It may be premature to conclude anything,” an expert advisor on manufacturing issues added.

The Mohali site original belonged to Ranbaxy, a company that Sun Pharma acquired as part of a $4 billion deal completed last year. Ranbaxy’s manufacturing sites in India at Paonta Sahib, Dewas, Toansa and Mohali were put under an Import Alert as part of drawn-out investigations. In 2013, Ranbaxy paid $500 million to settle the dispute with the US FDA.

According to sources, the US FDA is presently carrying out a thorough investigation of Sun Pharma’s crucial site at Halol, Gujarat. Clearance of Halol site is crucial to Sun Pharma as the site contributed about 15% of Sun Pharma’s revenues in the US. For FY2016, Sun had combined sales of $4.3 billion of which the US alone contributed $2.1 billion.

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